Shubh Goel on Niagara Trial Results and AstraZeneca’s Global Impact

Shubh Goel, the VP and Head of Immuno-Oncology and GI Tumors at AstraZeneca, joins host Amalya Sargsyan, the CRP at the Immune Oncology Research Institute, to discuss significant advancements in oncology on OncoDaily. Goel covers the promising results of the Niagara trial with Durvalumab and chemotherapy, along with other key trials like Potomac and Nile.

Shubh Goel is the Vice President, Head of Immuno-Oncology and GI Tumors Franchise for US Oncology at AstraZeneca, She is responsible for monitoring all sales, marketing, and cross-functional team efforts across the Immuno-Oncology portfolio of indications and GI sales teams. Previously, she was Chief Commercial Officer of Fennec, a late-stage biotechnology company dedicated to improving the lives of children with cancer.

Amalya Sargsyan is a Medical Oncologist at Yeolyan Center, a Research Physician at the Immune Oncology Research Institute, and Senior Editor at Oncodaily. She holds an MD from Yerevan State Medical University and an MSc in Precision Medicine from the University of Cyprus.

Dr. Sargsyan completed her clinical training at the Bank of Cyprus Oncology Center and has been honored with an ASCO IDEA award.  Her research focuses on the potential of novel immune checkpoint inhibitors (ICI) in low- and middle-income countries (LMICs), aiming to bridge disparities and enhance access to innovative cancer care.

00:00 Recap
01:04 Introduction
01:45 AstraZeneca Role
02:55 Niagara Trial Overview
05:00 Safety and Toxicity
05:32 Niagara Trial Name
07:55 Exciting AstraZeneca Studies
12:40 Pipeline Drug Insights
15:40 Global Access Expansion
17:00 Commitment Secret
19:00 Final Thoughts

Amalya Sargsyan: Hello, everyone, and welcome to OncoDaily. I’m Amalya Sargsyan, and today I’ll be your host. Today, we have our honor of welcoming vice president and head of immuno-oncology and GI tumors franchise of U.S. oncology business unit of AstraZeneca, Asif Gavil. Thank you for joining us and accepting our offer. It’s our pleasure to have you today with us.

Shubh Goel:  Thank you so much for having me. I’m excited to be here.

Amalya Sargsyan: So today we are going to explore some recent breakthroughs and advances in oncology, as well as think about future and what the future holds for us. And do you mind telling us a little bit more about you, your role in AstraZeneca and your background?

Shubh Goel: Yes, I’m happy to. So I joined AstraZeneca just over two and a half years ago. I have been in the oncology space for more than 20 years.

I started my career as a biochemist in the science side and then moved over to the commercial side of the business because I was really driven by bringing patients new therapies and really seeing the difference that they could make. Super excited to be at AstraZeneca and really kind of be a part of our growing portfolio where I really think we’re bringing meaningful differences to patients across the realm of targets and agents that we have. Immuno-oncology being one of those areas.

Amalya Sargsyan: Yes. Thank you for sharing what inspires you to do your work and thanks for the great job you are doing already. And less than a month ago, AstraZeneca announced the results of the Niagara trial.

It was a phase three trial where Durvaluma with chemotherapy demonstrated improved results with the fund for survival, overall survival in muscle-invasive bladder cancer, right? So can you tell us a little bit more about this trial? Design, which countries were involved?

Where did you start? And a little bit more details on it.

Shubh Goel: Yes, of course. So the study was a global study across multiple centers. I actually don’t have at hand all of the countries that were involved, but there were a number of countries around the globe that were involved.

It was a phase three study, as you mentioned. We are excited to see the positive high-level results that we press released recently, and that is of infimsy in combination with chemotherapy, both in the preoperative and then postoperative setting. So what we call perioperative setting.

And what was really exciting about the study is we actually saw that we achieved clinically meaningful improvement and statistically significant improvement in the primary endpoint of EFS, which is event-free survival, and also the key secondary endpoint of overall survival. And that was versus neoadjuvant chemotherapy alone. So, you know, I think you might be aware that patients usually will receive a cystectomy or bladder removal during this process.

So we’re really looking at the addition of IO before and after that process. So then again, oh, sorry.

Amalya Sargsyan: You can go ahead, please.

Shubh Goel: No, I think, you know, last thing I think that answered your question is this is the first immunotherapy regimen to read out this kind of event-free survival and overall survival benefit in this bladder cancer space. So why we’re super excited about it.

Amalya Sargsyan: Yes, it’s very encouraging to hear about it. So this makes Druvalubum the first one to be before surgery and after surgery. And also, as you have mentioned, besides overall survival data is also important, the quality of life of patients.

And if we can preserve from these surgeries, it will be a major success. And so coming back to the results you have shared already, very promising efficacy data. Can you share with us a little bit more about safety data, too?

What were toxicities? Were they manageable? What were major side effects that you are seeing with this trial?

Shubh Goel: Yes, at a high level, we know that infirmity was generally well tolerated and the safety concerns were consistent with, you know, what you would expect to see in a neoadjuvant or adjuvant setting. There will be more detailed safety reading out when we present the data at an upcoming conference, which, you know, we’re eager to see this at ESMO in the future.

Amalya Sargsyan: Oh, so we’ll keep our fingers crossed for the results in ESMO. And I think this interests a lot of listeners. Why it is called Niagara?

What is the story behind it?

Shubh Goel: You know, I don’t actually know the answer to that question, except that, you know, we’ve had a strategy of sort of thinking about themes for our studies. And so in the bladder cancer space, we have followed rivers. So across the bladder cancer paradigm, you know, we have Niagara in this intermediate setting.

We’re also looking forward in the future to see a readout from Potomac, which is an earlier setting of non-muscle invasive bladder cancer. And then we’re also looking for a readout of the Nile study, which is in more advanced stages of bladder cancer. And so you can see we have a bit of a river theme.

I can’t tell you where the river theme came from, but it does sort of combine our bladder cancer approach.

Amalya Sargsyan: Yeah, it actually makes connection with bladder and this falls. And yeah, this idea and hopefully we’ll get huge results like the Niagara. So you have partially actually answered my next question, which I was going to ask about what are the expected results to be published?

So you thought that a small will be the first one we will see the results. And when do you see the end of the trial and when to expect the final ones?

Shubh Goel: You know, I don’t actually know the answer to that question. I think, you know, largely, you know, everything being event based, it’s hard for us to predict. So we’d have to keep you posted on that.

I think what’s really exciting, though, here is that we’re actually already seeing a clinically meaningful benefit in overall survival, which is usually what we’re waiting for as we’re continuing to wait for readouts of studies. So, you know, I think at this at this early stage, seeing those two endpoints read out is really exciting to see.

Amalya Sargsyan: Yes, indeed, it’s we’ll wait for the future and see what it has and we’ll follow up on what happens next and how already we are seeing these good results. So we, I think, just confirm what we’ve got here. And it was very interesting about this trial.

And let’s a little bit go beyond this trial. Your role in AstraZeneca is working not only with this one. And can you share us about some studies that you are most excited for and you are waiting for results in AstraZeneca and which do you think that could be practice changing?

Shubh Goel: You know, that’s a really great question and almost a difficult one to answer as we have so much going on that I am excited about. Maybe I can tell you a little bit about our strategy in terms of how we think about trial development, AstraZeneca. And so, first of all, as you know, especially with the immuno-oncology portfolio, we’re really looking at areas of higher medical need where there hasn’t been an opportunity for patients to benefit from therapies to now or really need an improvement in therapies.

And so we look at that across the board, including the advanced setting. And as you already know, we had recently had approvals in the cholangiocarcinoma and BTC space, which has been a need area. And I’m looking forward in that vein to also see continued readouts and potentially in the future approvals for studies like Adriatic, which was the first study to read out a benefit in the limited stage small cell lung cancer space.

So, again, really high medical need with more than four decades of lacking in advancements for those patients. So that’s one area that I think we really are excited about. I think the other area is moving earlier into the disease state, because we really believe that the earlier you can intervene for a patient, the more likely we are to have a benefit on longer term outcomes.

And so just like Niagara, we have a number of perioperative studies across across some indications, including the Aegean study and respectable non small cell lung cancer, which has read out. We’re hoping to bring that to patients in the near future. And as also the Matterhorn study, which is in the gastric and gastroesophageal junction space, again, very similar to Niagara, where we are incorporating emphysema with chemotherapy ahead of surgery and then after surgery.

And we’ve seen the initial readouts of that study with PCR results. We are waiting on that study to read out EFS and OS. So more to come on that study.

But an area of real kind of focus for us in terms of moving earlier. Continuing on that moving earlier kind of thread, we also are now looking at a number of adjuvant studies as well. And so I already mentioned earlier disease studies.

So I already mentioned the Potomac study in bladder cancer as well. We also have an Emerald two, which is an adjuvant study design in HCC or liver cancer, hepatobiliary cancer, sorry, hepatocellular cancer. My my apologies.

And we also have, you know, within that earlier space, Emerald one and Emerald three, which are looking at intermediate patients as well. So slightly earlier than our current indicated space of Himalaya in the hepatocellular carcinoma space. So I think, you know, when you look at our pillars, we’re looking at high medical need where we can really make a benefit.

And then we’re looking to move earlier in disease to really try to affect outcomes earlier and really improve those longer term survival opportunities.

Amalya Sargsyan: Yeah, thank you for sharing this comprehensive AstraZeneca strategy, I believe. And yeah, just to sum up. So you say that we started with the advanced stage and then we are going to the early stage because we believe that it could be helpful for early stages.

Is this right? Yeah, indeed. This ASCO was full of results and hopefully we’ll see some more updates at ESMO and keep updated and hopefully we’ll have follow up calls and follow up updates on the trials as well.

And just as we are moving through what is done and what is waiting, if you already know, Oncodeli had an article about 10 most promising cancer drugs, which are not yet approved in solid tumors in 24. And for our listeners who are not familiar with this article, we’ll put the link in our description. And what is a huge success, I think, for our company too, is that from 10 to where from AstraZeneca.

And it was that the bottom of their Instagram and our editorial team believe that these drugs are going to be approved soon. And hopefully we’ll have the list which moved these drugs from not approved to approved one. We saw the potential there.

Congratulations on being on this list. And just to share your ideas about it, can you share a little bit more about these drugs and just in general? And when do you expect them to be moved from the approved list?

And if you have on your pipeline more drugs that you think have the greatest potential that to be approved, what would you suggest for our 2025 edition?

Shubh Goel: Yeah, so I think talking about approvals is a little bit hard. And, you know, I will certainly say I’m not the closest to the two drugs you mentioned. However, we are super excited about sort of the progress that both of those drugs are And again, the advancements that we’re making for patients.

And thank you for having us on the list and sort of recognizing the portfolio. I think AstraZeneca, you know, look, we have a bold ambition to eliminate cancer as a course of death. And I think what I when I look at our portfolio, you know, we have we have products like the ones you mentioned that are slightly closer to approval.

And then we have products that are further away that, again, could bring us the next wave in the future. And I think that’s what I’m most excited about. When we think about our portfolio, we think about it in terms of really being able to combine mechanisms across multiple different modalities so that we can continue to improve outcomes, you know, potentially improve those longer term survival benefits, especially if we’re able to move earlier and improve the quality of that cancer care, if we can start to eliminate chemotherapy.

And so that’s our overall goal. If you look at our portfolio, sort of looking into the future, we have, you know, really committed to a couple of areas in a big way, including ADCs like Dato, as well as more a follow on immunotherapies. And I think, you know, for me, I look at that and look at sort of the wave of the by specifics that are coming in the future.

And, you know, we really have an opportunity, hopefully, to continue to improve outcomes. But now with one compound or regimen versus a combination or a cocktail, be able to potentially combine within our own portfolio and eliminate chemotherapy and really start to affect those longer term outcomes in a bigger way. So, you know, what I will say to your question is we’re committed for the long haul.

We’d like nothing more than to be put out of business by eliminating cancer. And I think we have a portfolio ahead of us that can really help us do that with a multitude of different agents and targets that we can combine.

Amalya Sargsyan: Yes, thank you for sharing your insights. And indeed, we are living in the times that this is rapid development and we’ve seen moving from chemotherapy to chemotherapy free regimens for a lot of cancers already with very durable responses and results. And hopefully we’ll have more coming.

And you have mentioned that combining therapies and acting could be another key of success to finding the best way to go forward. And hopefully we’ll see another drug seen over 2025 list. Let’s keep our fingers crossed and just on a different road.

In the past decades, immunotherapy had a major role in impacting the cancer care and continuing to do so. But within all of these breakthroughs, it is not usually accessible to a lot of population. So how do you see this on the global perspective for low middle income countries, expanded access or maybe expanding clinical trials across the globe?

So how do you think making it more accessible?

Shubh Goel: Yeah, no, it’s a great question. I think it’s something that AstraZeneca is truly committed to in terms of really not just bringing therapies to market, but thinking about health equity and access to care, not just in the United States, although it’s as important in the United States, but globally. So we have a number of programs that are ongoing.

And I will say that one of the areas that we really do focus on is within the United States, thinking about, you know, starting with health equity in terms of access to clinical trials, right as the clinical trials are being put into place. And we’re continuing to work on that all the way through to making sure that patients have access and various appropriate mechanisms that we can. And so more work to do.

We continue to work on it, but definitely an area of commitment for AstraZeneca.

Amalya Sargsyan: Yes, thank you for sharing this. Hopefully more and more people can have these life saving drugs because, yes, we are already seeing huge potential in these drugs and it changed a lot how cancer treatment is working. And just to sum up from the trial results and so on, I have last question, more personal one.

So what keeps you going in this field? It is a drug development, a lot of failure, a lot of drugs are not going to go through, but you are committed and doing what makes you believe in the drugs and do what you are doing. So what is your secret?

Shubh Goel: Oh, I don’t know the answer to that necessarily. I think, you know, I’m super motivated and excited to see the continued advances to help patients with armament medical need. If I come back to the Niagara study, right, this is the first study to read out in muscle invasive bladder cancer that really allows patients potentially in the future to think about an immunotherapy option that can potentially prolong survival.

That’s really amazing. And I think that’s what really motivates me. Then I look at our portfolio, as we just discussed, and we have a number of those readouts across multiple different tumor areas.

And every time it makes us so proud to be able to bring that difference to patients. And that’s what really keeps me going. I’m excited for what we have today in our portfolio and what we’re able to bring to patients.

I remain motivated by all the readouts we have that allow us to bring more of this regimen to more patients in different tumor areas where there hasn’t been something before. And then as we look forward to our portfolio, I really do think that we have the opportunity to continue to really make a difference across multiple different cancer areas. And I feel very passionate about doing that.

Amalya Sargsyan: Yes, that seems like a motivation when you’re seeing good results and you know that you can help and be life changing and not to one person, but a whole population of cancer patients. Yes, it could be a motivation. Thank you for sharing your secret cocktail about being inspired and working and going to all this hard work you are doing.

It’s incredible. And thank you for accepting our invitation and being today with us. It was very interesting.

And hopefully we’ll see more results coming from other trials and we’ll follow up on that. And thank you for being us. If you have anything to conclude, we are happy to hear that.

Shubh Goel: Thank you so much for having me. And again, I think we’re super excited to really bring Niagara to now bladder cancer patients with the introduction of infimacy. So hopefully we’ll be chatting again in the future as that study continues to read out.

But thank you so much for the time today.

Amalya Sargsyan: Thank you for being with us and stay tuned on Oncodaily updates on latest clinical trials.